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Michael John Allingham, Priyatham S Mettu, Scott W Cousins; Elamipretide, a Mitochondrial-Targeted Drug, for the Treatment of Vision Loss in Dry AMD with High Risk Drusen: Results of the Phase 1 ReCLAIM Study. Invest. Ophthalmol. Vis. Sci. 2019;60(9):361.
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To report the results from the high-risk drusen (HRD) subgroup of the ReCLAIM Study, an open-label, phase 1 clinical trial to evaluate safety, tolerability, and efficacy of elamipretide in participants with intermediate age-related macular degeneration (AMD).
Open-label, phase 1 clinical trial of daily subcutaneous elamipretide (40 mg) for 24 weeks in individuals with dry AMD. For the pre-defined HRD subgroup, HRD was defined as presence of either at least 1 large (≥ 125 μm) druse or multiple medium-size (between 63 and 124 μm) drusen. Eyes with any geographic atrophy were excluded from the HRD subgroup. A single eye of each participant was eligible if ETDRS best-corrected visual acuity (BCVA) was ≥55 letters with low luminance VA (LLVA) deficit > 5 letters. LLVA was measured as best-corrected ETDRS VA through a log 2 neutral density filter and LLVA deficit was defined as the difference between BCVA and LLVA. Safety and visual function assessments occurred every four weeks, with outcomes assessed at week 24.
Subcutaneous elamipretide was safe and well tolerated with no treatment-related serious adverse events. Among participants in the HRD subgroup (n=21, age 70.9, 61.9% female), mean BCVA at baseline was 79.6 ± 7.3 letters, with mean increase of 3.6 ± 6.4 letters (p=0.03) at week 24. Mean baseline LLVA was 63.7 ± 9.8 letters, with mean increase of 5.6 ± 7.8 letters (p=0.006). Mean best-corrected reading acuity under standard lighting conditions (BCRA) (tested using MN read acuity chart) at baseline was logMAR 0.01 ± 0.17, with mean increase of -0.11 ± 0.15 (p=0.005), equivalent to an approximately 1-line gain. Mean low luminance reading acuity through log 2 neutral density filter (LLRA) was logMAR 0.38 ± 0.22 at baseline, with mean increase of -0.28 ± 0.17 (p<0.001), equivalent to an approximately 3-line gain.
Elamipretide, a mitochondrial-targeted drug, is safe and well-tolerated and may improve vision in patients with intermediate (dry) AMD manifest as HRD.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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